Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

Summary

The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety. Objectives: * To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed. * To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations

Timeline

Start

2015-09

Primary completion

2016-04

Completion

2016-07

Publications

• Choi WS, Noh JY, Lee J, Choi JY, Lee JS, Kim MS, Kim HS, Bang J, Lavis N, Kim WJ. Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18-60 years of age in the Republic of Korea. Hum Vaccin Immunother. 2018 Mar 4;14(3):587-592. doi: 10.1080/21645515.2017.1381808. Epub 2017 Nov 17.

Drugs

Indications